This notice is to inform potential applicants that the FDA is revising RFA-FD-13-034, “Collaborating Centers of Excellence in Regulatory Science and Innovation (U01)."

The following revisions are being made to this FOA:

Part 2. Full Text of AnnouncementSection II. Award InformationFunds Available and Anticipated Number of Awards

Current Language:
FDA/OCS intends to fund an estimate of 1-2 awards, corresponding to a total of $1,400,000, contingent upon the availability of funds.

Revised Language:
FDA/OCS intends to fund an estimate of 1-2 awards, corresponding to a total not to exceed $1,400,000 in total costs (including direct and indirect costs) per budget year. The 1-2 awards will be combined, contingent upon the availability of funds. Application budgets may request funding in the amount of up to $1,400,000 per budget year for up to 3 years. Future year amounts will depend on annual appropriations and performance.

Section III. Eligibility Information

Current Language:Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Revised Language:Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.